SERum-bank for PANcreatic Cancer

Recruiting

• Conditions: Adenocarcinoma
• Interventions: Biological: Blood sample

• Registration Number: NCT04374175
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

This study is about pancreatic cancer. If the diagnostic cancer is done at an early stage (\<2cm), the chances of recovery are very good.

But the main problem is there is not any detections means for this cancer. Sadly, when there is a cancer diagnostic , it's already too late in the majority of cases, because the cancer is in an advanced case.

Today, there is no any effective means of detection... Blood markers can be a simple means of early detection

Detailed Description

The purpose of this study is to establish a sero-library in a case-control cohort to assess several potentially useful serum biomarkers, such as adiponectin in the early diagnosis of pancreatic cancer.

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Documented adenocarcinoma (cytology / anatomopathology), all stages, except if the tumor is immediately resectable and does not require preoperative cytological evidence. In this case, the inclusion and the first collection of the sero bank is done preoperatively. The diagnostic confirmation will therefore be made post-operatively at the risk of being excluded in the event of a different diagnosis.
• At the start of treatment (before surgery / 1st course of chemotherapy)
• Age ≥ 18 years
• Patient affiliated or entitled to a social security system

Exclusion Criteria

• Patient refusal
• Acute renal failure
• Child-Pugh B or C cirrhosis
• Patient under guardianship or curators
• Other synchronous cancer or history of cancer <5 years
• Language barrier

CONTROL GROUP

Inclusion Criteria:

• Age ≥ 40 years
• Patient affiliated or entitled to a social security system
• Digestive endoscopy for any reason other than cancer or chronic inflammatory bowel disease

Exclusion Criteria:

• Patient refusal
• Acute renal failure
• Child-Pugh B or C cirrhosis
• Patient under guardianship or curators
• Other synchronous cancer or history of cancer <5 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adenocarcinoma group	Blood sample	Patients with Adenocarcinoma will be included. They will have blood sample at the inclusion visit and at 3 months, 6 months, 9 months and 12 months after.
Control group	Blood sample	Patient with no adenocarcinoma will be included. They will have blood sample at the inclusion visit.

Primary Outcome Measures

Name	Time	Method
Serum adiponectin concentration	Months : 0	Measure by blood sample result Serum adiponectin concentration threshold for which the specificity will be 100% for the diagnosis of pancreatic cancer with a sensitivity of 80%.

Secondary Outcome Measures

Name	Time	Method
Overall survival	Months : 24
Progression-free survival	Months : 24
Serum CA19.9 concentration	Months : 0, 3, 6, 9, 12	Measure by blood sample result Threshold for Comparison of diagnostic performance compared to serum adiponectin concentration
Tumor response and progression rates according to RECIST v1.1	Month 12	Tumor response and progression rates defined according to RECIST v1.1 criteria according to a serum threshold of the prognostic biomarker to be identified by logistic regression analyzes.
Serum adiponectin concentration	Months : 3, 6, 9, 12	Measure by blood sample result Serum adiponectin concentration to correlate with cancer progression or not.

Trial Locations

Locations (2)

Institut Cancérologique Lucien Newirth (ICLN); 🇫🇷 Saint-Priest-en-Jarez, France

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France